NCT05657444

Brief Summary

A recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The study aimed to determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

December 2, 2022

Last Update Submit

March 27, 2025

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

  • proportion of favorable outcome

    Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2

    Day 90

Secondary Outcomes (14)

  • proportion of excellent outcome

    Day 90

  • proportion of successful reperfusion after the first-pass or final pass of endovascular treatment

    immediately after the first-pass or final pass of endovascular treatment

  • Distribution of modified Rankin Scale (mRS)

    Day 90

  • Change in cerebral circulation time after intervention

    immediately after endovascular treatment

  • occurrence rate of early neurological improvement

    24 (-6/+24) hours

  • +9 more secondary outcomes

Study Arms (2)

TNK group

EXPERIMENTAL
Drug: Tenecteplase

control group

NO INTERVENTION

Interventions

TenecteplaseDRUG

intra-arterial tenecteplase during endovascular treatment

TNK group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years;
  • Stroke patient with large vessel occlusion (internal carotid artery, M1 or M2 of middle cerebral artery, basilar artery, or intracranial segment of vertebral artery) who meets criteria for endovascular treatment within 24 hours of stroke onset;
  • The modified Rankin Scale (mRS) score before onset ≤ 2;
  • ASPECTS 6 or greater on CT
  • Signed informed consent.

You may not qualify if:

  • hemorrhagic stroke;
  • Tandem occlusion;
  • Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\<100000/mm3);
  • Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), elevated serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
  • Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
  • Patients with contraindication or allergic to any ingredient of drugs in our study;
  • Pregnancy, or plan to get pregnant or during active lactation;
  • Suspected septic embolus or infective endocarditis
  • The estimated life expectancy is less than 6 months due to other serious diseases;
  • Other conditions unsuitable for this clinical study as assessed by researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, 110840, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen ActivatorSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neurology

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 20, 2022

Study Start

March 21, 2023

Primary Completion

March 20, 2025

Study Completion

March 20, 2025

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations

CN(1)